NOVARTIS

Regulatory snapshots: global drug submissions, approvals, clinical trial approvals, and other decisions involving Accord, Applied, Astrazeneca, Azitra, Briacell, Glycomine, Imcheck, Merck, Moderna, Nicox, Novartis, Valneva.

FDA approves Kisqali (ribociclib) with aromatase inhibitor for HR+/HER2- stage II/III early breast cancer, reducing recurrence risk by 25.1% in NATALEE trial. Kisqali, a CDK4/6 inhibitor, is taken orally for three years, showing a well-tolerated safety profile. The approval broadens treatment options for high-risk patients, including those with N0 disease.

FDA expands approval of Kisqali for early-stage breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years. The drug is now available for HR-positive, HER2-negative breast cancer patients in stages 2 and 3, with potential long-term benefits and high costs.

A study in The BMJ reviews drug interventions for migraine, emphasizing triptans' efficacy and need for wider access. Experts highlight the importance of comparing new drugs to current treatments and involving patients in research design. The study also notes limitations in trial heterogeneity and individual patient insights.

Pharmaceutical industry inefficiencies stem from high costs per drug approval, frequent C-level executive changes, and strategic R&D restructuring unrelated to science. AI-drug discovery companies should commit to programs until Phase I completion to avoid waste and maximize patient benefit.

FDA approves Kisqali for early-stage breast cancer, reducing recurrence risk by 25%. Phase III trial showed a 25.1% reduction, with a 28.5% risk reduction after four years. Dr. Dennis J. Slamon calls it a 'pivotal moment in improving our approach to care.'

FDA approves Kisqali for early-stage HR-positive, HER2-negative breast cancer, reducing recurrence risk by 25% when taken with aromatase inhibitors for 3 years.

The FDA expanded approval of Kisqali, a CDK4/6 inhibitor, for early-stage HR-positive, HER2-negative breast cancer, reducing recurrence risk by 28.5% after four years when combined with endocrine therapy. This approval broadens access to a broader patient group compared to similar drugs like Verzenio, which is limited to high-risk cases. The cost of Kisqali over three years is approximately $300,000-$400,000, but insurance coverage is expected to increase.

FDA approves Novartis’ Kisqali for early breast cancer at high risk of recurrence, including node-negative disease, potentially adding $3B to annual sales. Kisqali now covers a broader population than competitor Lilly’s Verzenio. Based on NATALEE trial results, Kisqali plus endocrine therapy showed a 25.1% reduction in recurrence risk.

Novartis' Kisqali gains broad FDA approval for early HR+/HER2- breast cancer, reducing recurrence risk by 25% in NATALEE trial, surpassing Eli Lilly's Verzenio in node-negative cases. Kisqali's potential to reach $7 billion in sales is boosted by this approval.